Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

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Patent ductus arteriosus
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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Official Title

Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance

Brief Summary

      The purpose of this post-marketing clinical use database surveillance is to observe the
      frequency, type, and degree of adverse device effects and adverse events in order to assure
      the safety of the medical device, and to collect safety and efficacy information for
      evaluating the results of its clinical use.

Detailed Description

      The Surveillance will be conducted per the standards required by the Ministry of Health,
      Labour and Welfare (MHLW) and in the standards for post-marketing surveillances and studies
      [except for those defined in the Ministerial Ordinance on Good Clinical Practice for Medical
      Devices (MHLW Ordinance No. 36, 2005)] based on Paragraph 4, Article 23-2-9 (including
      application mutatis mutandis per Article 23-2-19 of Revised PAL) of the Law on Securing
      Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc. (Law No. 145, 1960,
      hereinafter referred to as "Revised PAL") by the Marketing Authorization Holder or accredited
      foreign manufacturer of a medical device defined in Paragraph 1, Article 23-2-5 of Revised
      PAL.

Study Type

Observational [Patient Registry]

Primary Outcome

The rate of major complications through 180 days after an attempted Piccolo device implant

Condition

Patent Ductus Arteriosus

Intervention

Amplatzer Piccolo Occluder

Study Arms / Comparison Groups

 Amplatzer Piccolo Occluder
Description:  Amplatzer Piccolo Occluder device implant

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

70

Start Date

April 1, 2020

Completion Date

May 31, 2025

Primary Completion Date

October 31, 2022

Eligibility Criteria

        Inclusion Criteria:

        The device is used to percutaneously close the PDA of a patient who meets all of the
        following:

          -  PDA ≤4 mm in diameter

          -  PDA ≥3 mm in length

          -  Weight ≥700 g

        Exclusion Criteria:

          -  Age <3 days

          -  Coarctation of the aorta

          -  Left pulmonary artery stenosis

          -  Cardiac output that is dependent on right to left shunt through the PDA due to
             pulmonary hypertension

          -  Thrombus in the implant site, or sign of venous thrombus in a vessel in which the
             occluder is inserted and delivered

          -  Endocarditis, or infection that can cause bacteremia

          -  Allergic or potentially allergic to nickel

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, +81-3-3524-1792, [email protected]

Location Countries

Japan

Location Countries

Japan

Administrative Informations

NCT ID

NCT04371081

Organization ID

ABT-CIP-10290

Responsible Party

Sponsor

Study Sponsor

Abbott Medical Devices

Collaborators

 Japanese society of Congenital Interventional Cardiology

Study Sponsor

, ,

Verification Date

April 2020